SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients

Overview

The study duration for an individual patient will include a screening period for inclusion of up to 21 days, the treatment period may continue until disease progression, unacceptable adverse reaction or other reason for discontinuation. After study treatment discontinuation an end of treatment (EOT) visit will be done at 30 days to assess safety, and at 30 and 60 days for ADA and PK. If the ADA is positive or inconclusive at day 60 then PK and ADA will be repeated every 30 days until ADA is negative. Patients who discontinue treatment for reasons other than progression of disease will be followed every month until progression or initiation of subsequent therapy, for a maximum of one year, whichever comes first.
SparkCures ID 735
Trial Phase Phase 1
Enrollment 24 Patients
Treatments
Trial Sponsors
  • Sanofi
NCT Identifier

NCT02283775

CLOSED

This trial has completed.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion criteria:

  • Patient has been previously diagnosed with multiple myeloma (MM) based on standard criteria and currently requires treatment because MM has relapsed following a response, according to International Myeloma Working Group (IMWG) criteria and is refractory to the most recent treatment.
  • Patient had received at least two previous therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy.
  • Patients with measurable disease defined as at least one of the following:
  • Serum M protein ≥0.5 g/dL (≥5 g/L)
  • Urine M protein ≥200 mg/24 hours
  • Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).

Exclusion criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status >2. Poor bone marrow reserve. Poor organ function. Known intolerance/hypersensitivity to IMiDs, dexamethasone, boron or mannitol, sucrose, histidine or polysorbate 80.
  • Any serious active disease (including clinically significant infection that is chronic, recurrent, or active) or co-morbid condition, which, in the opinion of the investigator, could interfere with the safety, the compliance with the study or with the interpretation of the results.
  • Any severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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